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Sodium Restriction in the Management of Cirrhotic Ascites

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ClinicalTrials.gov Identifier: NCT00548366
Recruitment Status : Terminated (Failure to recruit.)
First Posted : October 23, 2007
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.


Condition or disease Intervention/treatment Phase
Ascites Other: Sodium restriction Phase 4

Detailed Description:

Secondary objectives:

  1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
  2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
  3. Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites
Study Start Date : October 2007
Primary Completion Date : December 2009
Study Completion Date : September 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
4 gram sodium diet
Other: Sodium restriction
4 gram sodium diet
Other Name: No added salt diet
Active Comparator: 2
2 gram sodium diet
Other: Sodium restriction
2 gram sodium diet
Other Name: Low sodium diet


Outcome Measures

Primary Outcome Measures :
  1. Control of ascites [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Patient acceptance and compliance [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
  • Age 18-75
  • Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
  • Spanish-speaking subjects will be eligible for participation

Exclusion Criteria:

  • Active drug or alcohol abuse,
  • Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
  • Hemorrhagic ascites, malignant ascites,
  • Creatinine >2 mg/dL or CCl < 30 mL/min,
  • K > 5.5 mmol/L,
  • Diuretic refractory ascites
  • Allergy to or intolerance of either spironolactone or furosemide
  • Homelessness, incarceration, inability to follow up in clinic, or comply with diet.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548366


Locations
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Director: Jennifer A Cuthbert, M.D. UT Southwestern Medical Center at Dallas
More Information

Responsible Party: Jennifer Cuthbert, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00548366     History of Changes
Other Study ID Numbers: UTSouthwestern 062007-066
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Keywords provided by University of Texas Southwestern Medical Center:
cirrhosis
portal hypertension
ascites
sodium restriction

Additional relevant MeSH terms:
Ascites
Pathologic Processes